Quality Priorities

December 12, 2005

MINUTES
Kidney Care Quality Initiative Steering Committee
December 12, 2005
Washington, DC

Steering Committee Attendees:
Bill Henrich, American Society of Nephrology (ASN)
Alan Kliger, Renal Physicians Association (RPA)
Mike Lazarus, Fresenius Medical Care North America (FMC)
Maureen Michael, National Renal Administrators Association (NRAA)
Kent Thiry, DaVita
David Warnock, National Kidney Foundation (NKF)
Sandy Watkins, American Society of Pediatric Nephrology (ASPN)
Gail Wick, American Nephrology Nurses Association (ANNA)
Linda Keegan, Kidney Care Partners (KCP)
Kathy Lester, Patton Boggs and Kidney Care Partners (KCP)
Julie Black, Patton Boggs
Lu Zawistowich, Patton Boggs
Amy Yenyo, Patton Boggs

Work Group Attendees:
Bill Haley (by phone), representing the Clinical Measures Work Group
Charlie McAllister, representing the Clinical Measures Work Group
Bill McClellan (by phone), representing the Quality of Life/Patient Perspective Work Group Allen Nissenson (by phone), representing the Pay-for-Performance Work Group
Barbara Fivush, representing the Pediatrics Work Group

Discussion of the KCQI Process Rules
The Steering Committee considered draft process rules that staff prepared based upon the rules adopted by the National Quality Forum (NQF). Members discussed the roles of the various groups within the KCQI, including the Kidney Care Quality Alliance (KCQA), the KCP Board, the KCP Steering Committee, and the Work Groups.

The Steering Committee members stressed the need to delineate clearly the roles of each of these groups. Dr. Kliger clarified that KCQI refers to the combined effort of these groups. The KCQA is part of this effort, but is a decision-making body independent of the KCP.
The members expressed concern for the use of the phrase “literature review” to describe the activity of the Work Groups and recommended that it be modified.

Members also questioned how disagreement between two KCQI groups would be resolved and the overall structure of the KCQI. The members discussed whether approval from KCQA is required before moving the product to the legislature. Many members have spoken with CMS regarding this effort.

In addition, once the KCP Board has approved the final documents and the Steering Committee transmits them to the KCQA, they will be posted on the KCQI section of the KCP website. It is also likely that, given the timing of bill introduction, the concepts proposed in the documents may be discussed with key congressional staff before KCQA approval. The group also discussed the idea that the KCQA will prove most helpful in the development of appropriate metrics rather than on the structure of a pay-for-performance program.

The group expressed concern about determining a governance structure for the KCQA without input from KCQA members and concluded that the KCQA should have an opportunity to review and comment on its own process document.

STAFF ACTION ITEM: 
The staff will create an organizational chart with functions, responsibilities, and definitions of the groups that are part of the KCQI.

The sections of the process document that relate to KCQA approval and appeals will be placed in a separate document. The KCQI purpose will be amended to give the Steering Committee the responsibility to review the process and revise it as necessary. Guided by the Steering Committee consensus, the word “literature” in the Development of Work Group.

Discussion of the Pediatric Work Group Membership
The Pediatrics Work Group now has two nominees for a patient-parent member. The Steering Committee determined that the names of the nominees along with descriptions should be circulated.

STEERING COMMITTEE ACTION ITEM:
The committee will decide upon a parent-patient member for the Pediatrics Work Group via email.

Discussion of the Guiding Principles
The Work Groups have recommended changes to the Guiding Principles. The Pay for Performance Work Group would like a provision noting that cherry picking will be avoided. Additionally, the Quality of Life Work Group requests that the principles state that metrics should be equitable.

STEERING COMMITTEE ACTION ITEM:A redlined copy of the Guiding Principles will be circulated via email for approval.

Discussion of Quality of Life Work Group Product 
Dr. McClellan provided background on the group’s work and reported its recommendations. He noted that the current knowledge base for quality of life and patient satisfaction metrics and tools is incomplete, and incorporating them into a pay for performance program may require a pilot study.

The Work Group members identified several tools that can be used to measure quality of care; however, evidence to support their validity does not exist. The members recommend that a pilot program to study these tools be conducted before any one is used. The Steering Committee agreed with the Work Group members that CAHPS® is not an appropriate tool and that other tools should be explored.

The Steering Committee discussed the use of the term “surrogates” in the document. Dr. McClellan agreed that the term could be changed to indicate that the metrics being discussed represent modified risk factors that affect the quality of life of patients.

Others emphasized the need to be clear about the differences between quality of life and patient satisfaction. Dr. McClellan stated that the Work Group during Phase II should collect more information about measuring patients’ quality of life. He suggested that KCP members provide access to patients for USRDS to conduct a study. The Steering Committee agreed that research is an important aspect of the KCQI.

The Work Group recommends that quality of life process measures be included in the final recommendation to CMS and Congress and that there should be studies investigating the usefulness of quality of life outcomes-based measures. Dr. Fivush indicated that in the pediatric context, she is working with a group that has an Institutional Review Board (IRB) exemption to evaluate quality of life in nine ESRD networks. Dr. McClellan stated that it would be important to obtain IRB exemptions for such studies in adults as well.

WORK GROUP ACTION ITEM:
The Quality of Life/Patient Perspective Work Group will amend its proposal based upon the suggestions from the Steering Committee. The term “modified risk factors” will replace “surrogate” in describing the measures.

Discussion of Pay for Performance Work Group Product
Dr. Nissenson stated that Pay for Performance is a politically correct approach to improving quality; however, it is not the solution. He noted that flaws in the payment system must also be addressed in a way that will not disadvantage underserved populations. Dr. Nissenson walked the Steering Committee through the Work Group’s recommendation. When discussing the document’s wording, the Steering Committee recommended clarifying the difference between hospital-based providers (providers) and independent dialysis facilities (facilities).

The Steering Committee agreed with the Work Group recommendation that, during the first year, providers/facilities would be reimbursed for reporting specific measures. If facilities do not report data, they will not be paid. During the next 2-3 years, providers/facilities would be awarded bonus payments based on a quintile system, which would be based on a set of quality indicators used to determine a composite score. Payments would not come from a withhold, but rather be tied to an annual update. Ultimately, payments would come from gain-sharing.

The Steering Committee asked the Work Group to specify that the pool of money would be fully distributed, even if all facilities do not report data during the first year.

They also agreed with the Work Group that while the community deserves an annual update mechanism outside of the context of pay for performance, it may be appropriate to link the two ideas based upon current political realities.

The Steering Committee asked whether facilities and physicians would have the same composite score. Dr. Nissenson welcomed suggestions on this matter, noting that the Work Group has not discussed the topic and would do so during Phase II.

The Steering Committee discussed the role of the ESRD Networks and the ESRD Advisory Committee at length. Members expressed varying opinions about formalizing the role of ESRD Networks into a pay for performance program. In the end, the Steering Committee agreed that it is important to have an organization that facilitates quality improvement among facilities and providers, which may or may not be the ESRD Networks.

The Steering Committee members suggested that KCQI have someone to communicate these ideas to CMS and to ask the Agency what they would like to see in terms of membership and charge of an ESRD Advisory Committee to prevent appearing self-controlling.

The Steering Committee agreed that incorporating health information technology (HIT) is critical to a pay for performance program. Members also suggested that the community work on its own HIT system to present to CMS. They agreed the central reporting system should not be VISIONS.
In Phase II, the members also suggested that the Work Group develop criteria for picking review organizations, including credibility with Congress and CMS. In addition, the Work Group should consider how to incorporate peer review of the outcomes.

WORK GROUP ACTION ITEM: 
The Work Group will add language specifying that the pool of money will be distributed in its entirety, regardless of whether or not all facilities report data. The concept of the ESRD Advisory Committee will be explained earlier in the document. The concept of assisting poor performers will remain in the document without reference to the ESRD Networks.

In Phase II, the Work Group will develop criteria for selection of review organizations and consider recommendations for an organization to complete a peer review of the evaluation.

Discussion of Clinical Measures Work Group Product
Dr. Haley described the Work Group’s review of existing ESRD and CKD measures for adults. He stated that the members recommend using six of sixteen K/DOQI performance measures. Dr. Haley pointed to the rendering of measures on a physical level and noted that the Work Group does not have this level of detail for its measures in this phase. Dr. McAllister summarized that the measures chosen include those on kinetics, target hemoglobin, vascular access (both fistula and catheters), vaccines (whether or not they are offered), and the PD side of kinetics.

The Steering Committee supported the Work Group’s efforts. Members also suggested the need for process measures related to patient safety. Dr. McAllister commented that there are issues with capturing the event in a reliable and predictable manner.

Responding to Dr. Fivush’s concern regarding collection of data on CKD, Dr. Kliger reiterated the Work Group’s charge to select ESRD measures and, to the extent possible, those for CKD as well. The Steering Committee suggested that, if any advanced CKD measures are recommended, they be included in a separate table. The Steering Committee also discussed the need for a group, such as an ESRD Advisory Committee, to determine the appropriate percentage of patients required to meet the measure and to encourage the evolution of measures over time.

WORK GROUP ACTION ITEM:
Advanced CKD measures will be organized in a separate table.

Discussion of Pediatrics Work Group 
The Steering Committee clarified that the charge of the Pediatrics Work Group is to focus on a pay for performance structure, clinical measures, and quality of life from the pediatric perspective. Given that the Work Group had met only once before this meeting, the Steering Committee agreed that it would be appropriate for the Work Group to develop specific pediatric sections for each of the documents created by the other Work Groups. In addition, the Pediatric Work Group could provide a summary document of their recommendations.

Dr. Fivush commented that the Pediatrics Work Group needs to review the DOQI guidelines. Additionally, the group may need to rethink what qualifies as evidence in the pediatric setting.

WORK GROUP ACTION ITEM: 
The work group will review the revised proposals and incorporate the Pediatric Work Group recommendations into those documents.

Discussion of Next Steps

Requests to Work Groups
Minutes with Work Group action items will circulate to the Steering Committee for approval.

Structure of Phase I Document
The Steering Committee determined that the comprehensive document should take the form of three distinct proposals with an executive summary serving as the cover letter.

Timeline
The weeks of December 12 and 19 will be used to finalize documents and draft a cover letter. On December 22 or 23, the Work Group documents will be circulated to the Steering Committee for review and approval. At this time the Steering Committee should also determine whether another conference call is necessary. The approved documents will be distributed the week of January 2 to the KCP Board to allow them to redline the proposal. The Steering Committee determined that all documents should be held until notice goes out to the board. At that time, Steering Committee members can look for approval from their associations. On January 9, the KCP Board will consider and vote on the proposal.

Please note: this timeline was not ultimately followed because of changes in the Budget Reconciliation legislation.

Budget
The Steering Committee members discussed the budget proposed by Ms. Keegan. All agreed that the budget is a KCP Board decision.

Outreach to CMS
Many members of the Steering Committee had invited Dr. Barry Staube, the Acting Chief Medical Office of CMS and Acting Director of the Office of Clinical Standards and Quality, to attend the meeting. Because he was not able to be in DC, he asked the members to update him at the end of the meeting. The Steering Committee tried several times to reach him, but he was unavailable. Members agreed to follow-up with him after the meeting.